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Early Warning and Optimization Strategy in Carotid Endarterectomy

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ClinicalTrials.gov Identifier: NCT01210937
Recruitment Status : Unknown
Verified September 2010 by Liu Chang-wei, Peking Union Medical College Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 29, 2010
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Liu Chang-wei, Peking Union Medical College Hospital

Brief Summary:
Carotid endarterectomy has been proven effective in prevention of cerebral vascular events in patients with severe carotid artery stenosis (symptomatic,>50%;asymptomatic,60%). But during the surgery, when the carotid artery is clipping, the patient will have the chance to have hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce the risk of death and nonfatal stroke in patients .

Condition or disease Intervention/treatment Phase
Carotid Stenosis Carotid Artery Diseases Stroke Vascular Diseases Procedure: CEA and TCD monitoring Phase 4

Detailed Description:
AHA guidelines recommend carotid endarterectomy (CEA) for severe carotid stenosis. But during CEA, there is little chance that the patient suffer from severe hypoperfusion or stroke. So we use TCD to monitor the blood flow of brain in the surgery and keep the blood pressure stable. The sudy is designed to find out whether the index which we found in previous work is more sensitive to show the blood flow of middle cerebral artery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Warning and Optimization Strategy in Carotid Endarterectomy
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: CEA and TCD monitoring
CEA involves a neck incision and physical removal of the plaque from the inside of the artery.During the surgery, the patient will be monitored by TCD.
Procedure: CEA and TCD monitoring
All patients will receive carotid endarterectomy. During the surgery, all of them will be monitored by TCD. Record the blood flow velocity and blood pressure on specified time.



Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure


Secondary Outcome Measures :
  1. cardiac and neurological morbidity (TIA and CVA) [ Time Frame: 12 months ]
  2. brain hyperperfusion [ Time Frame: 12 months ]
  3. long term recurrence [ Time Frame: 12 months ]


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Ages Eligible for Study:   40 Months to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Carotid artery stenosis detectable by duplex ultrasound, and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS.
  • Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG)
  • Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years)
  • Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA .

Exclusion Criteria:

  • Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210937


Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Liu Changwei, bachelor
Principal Investigator: Liu Bao, doctor

Responsible Party: Liu Chang-wei, Vascular Surgery, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01210937     History of Changes
Other Study ID Numbers: pumch-CAS
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: September 2010

Keywords provided by Liu Chang-wei, Peking Union Medical College Hospital:
Internal Carotid Artery Stenosis
Carotid Endarterectomy
Stroke
Cerebrovascular
Atherosclerosis

Additional relevant MeSH terms:
Vascular Diseases
Carotid Stenosis
Carotid Artery Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases